NCT02852512

Brief Summary

The aim of the study is to perspectively compare the anatomical and functional outcomes of Pelvic Organ Prolapse (POP) repair after Laparoscopic or Robotic-assisted Colposacropexy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

July 26, 2016

Last Update Submit

August 3, 2016

Conditions

Pelvic Organ Prolapse

Keywords

Laparoscopic SacrocolpopexyRobotic Assisted SacrocolpopexyPelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Anatomical outcome

    POP \<2 according to POP-Q system

    12 months

Secondary Outcomes (6)

  • Intraoperative ando post operative complications

    during surgery and within 90 days after surgery

  • post operative pain

    within 7 days after surgery

  • voiding and storage symptoms

    2, 6, 12 months after surgery

  • sexual dysfunctions

    2, 6, 12 months after surgery

  • patient satisfaction

    12 months after surgery

  • +1 more secondary outcomes

Study Arms (2)

Laparoscopic sacrocolpopexy

ACTIVE COMPARATOR

The surgical technique will be the same between the two approaches, in this arm the approach will be laparoscopic

Procedure: sacrocolpopexy

Robotic assisted Sacrocolpopexy

ACTIVE COMPARATOR

The surgical technique will be the same between the two approaches, in this arm the approach will be robotic assisted

Procedure: sacrocolpopexy

Interventions

sacrocolpopexyPROCEDURE

Peritoneal incision from the sacral promontory to the Pouch of Douglas. After careful dissection of the inter-rectovaginal space, a two-piece Y-shaped polypropylene mesh was fixed posteriorly to the levator ani muscles using a absorbable suture. The midpoint of the mesh is anchored to the posterior wall of the vagina. The anterior portion of mesh was then introduced and fixed within the intervesico- vaginal space to the anterior/apical vaginal wall with a running suture. The tails of both meshes were fixed to the sacral promontory with a strong non-absorbable polypropylene suture. The peritoneal incision was re- approximated with a running absorbable suture

Laparoscopic sacrocolpopexyRobotic assisted Sacrocolpopexy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic POP \>2 stage according to POP Q system

You may not qualify if:

  • Obesity
  • Heart failure (NYHA III-IV)
  • High stage COPD (Chronic Obstructive Pulmonary Disease)
  • Patients who underwent more than 2 previous abdominal surgical procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Maria della Misericordia Hospital- University of Perugia

Perugia, Italy, 06100, Italy

RECRUITING

Related Publications (3)

  • Lee RK, Mottrie A, Payne CK, Waltregny D. A review of the current status of laparoscopic and robot-assisted sacrocolpopexy for pelvic organ prolapse. Eur Urol. 2014 Jun;65(6):1128-37. doi: 10.1016/j.eururo.2013.12.064. Epub 2014 Jan 8.

    PMID: 24433811RESULT

  • Seror J, Yates DR, Seringe E, Vaessen C, Bitker MO, Chartier-Kastler E, Roupret M. Prospective comparison of short-term functional outcomes obtained after pure laparoscopic and robot-assisted laparoscopic sacrocolpopexy. World J Urol. 2012 Jun;30(3):393-8. doi: 10.1007/s00345-011-0748-2. Epub 2011 Aug 20.

    PMID: 21858540RESULT

  • Awad N, Mustafa S, Amit A, Deutsch M, Eldor-Itskovitz J, Lowenstein L. Implementation of a new procedure: laparoscopic versus robotic sacrocolpopexy. Arch Gynecol Obstet. 2013 Jun;287(6):1181-6. doi: 10.1007/s00404-012-2691-x. Epub 2012 Dec 30.

    PMID: 23274792RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Elisabetta Costantini, MD

    University Of Perugia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabetta Costantini, MD

CONTACT

+393393384370elisabetta.costantini@unipg.it

Ester Illiano, MD

CONTACT

+393283620614ester.illiano@inwind.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 2, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

August 4, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)